Events

Recall of Safety Glide

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Company.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    33966
  • Event Risk Class
    Class 2
  • Event Number
    Z-0404-06
  • Event Initiated Date
    2005-10-25
  • Event Date Posted
    2006-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42824
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Syringe, Piston - Product Code FMF
  • Reason
    Safety mechanisms on the syringes are rotating too freely. this can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick.
  • Action
    Recall notifications were sent to all direct consignees and potential end users on 10/25/2005 via UPS second day air.

Device

Safety Glide
  • Model / Serial
    Reference Number 305950: Product Description: 1 mL 27G Allergist Tray Lot Number:  5167180; 5167183; 5111316; 5111317; 5082354; 5082355; 5052282; 5020329; 5020326; 4344954; 4344973; 4323198; 4323202.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed nationwide to 450 consignees composed of wholesalers, hospitals, and medical supply distributors. There is a Canadian customer, Dufort & Lavigne, Montreal, Quebec, Canada. Government customers include VAMC New Orleans, New Orleans, LA; Fox Army Health Center, Redstone Arsenal, AL; Moncrief Army Community Hospital, Columbia, SC; US Naval Med. Ctr., Portsmouth, VA; USAF Hill AFB 649 Medical Group, Hill Air Force Base, UT; VAMC Ann Arbor, MI; VAMC East Orange, NJ; VAMC Tuskegee, AL; McDonald Army Community Hospital, Newport News, VA.
  • Product Description
    BD 1 mL Allergist tray with 27 G x 1/2 in. BD Safety Glide.
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Manufacturer Address
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA